Read the Conversation

EF: If you had to design a healthcare initiative or startup, what would it be?

BS: There are three critical needs, that could be addressed at a very national level. Finding a way of partnering between the public sector and the private sector to improve the healthcare infrastructure. To some extent, that is what the NHI (National Health Insurance) is trying to address. The second intervention would be around human resources. We need to ensure we have adequate healthcare service provider capacity. This can be achieved by partnering with universities, technical institutions, and even the private sector. We need to explore new ways of building capacity, and with technology and digitization, the possibilities are endless. We can leverage programs applied in different countries and offer them locally through digital platforms. There are inexpensive mechanisms to build capacity and you can leverage what is available internationally. It is infrastructure, its people, and then the third element, and here I am going to critique my own work and my own institution, is creating an enabling environment for access to healthcare products, which is something that we are focusing on as a regulator. We need to look at what the obstacles to product access are. People are innovating, but usually, it is about accessing the market, whether it is from a procurement perspective, etc. We need to pull together the different stakeholders that play a role along the value chain and create mechanisms that enable easy access to products.  

EF: As a regulator, how are your priorities shifting or evolving now that the pandemic is fading away?

BS: I joined the regulator in January 2020, and you can imagine that in March, we went into lockdown. For the last three years, I have been dealing largely with COVID, among other things. Now, some of our priorities include supporting and enabling local manufacturers, especially in the context of the continental discussion on vaccine manufacturing. This extends beyond just vaccines to local manufacturing across the continent. As a regulator, we need to consider what role we play in enabling this continental ambition and intention. We also need to reevaluate our regulatory processes to ensure that we do not become a barrier. As a regulator, policing is always an important element of our function to ensure that products are trusted. Therefore, we are reviewing many of our guidelines and frameworks to determine their relevance in supporting the local industry. Most of our guidelines and frameworks assume that products are imported, so we may not cater to certain aspects of locally manufactured products. Another priority is to ensure that we have the necessary skill sets as regulators with the increase in manufacturing and complexity of new technologies and platforms. To support those innovations, we need to ensure that we have the skillsets. So, there is that element of saying, let us train our people. So, we work a lot with other regulators. And then from a therapeutic area perspective, there is a lot happening in the area of HIV. You may have seen the recent approval that we made of a long-acting cartographer. Again, they used a new formulation, a nanotechnology-based formulation. We do not get many nanotech formulated products. We must ensure we are keeping up with the development in the specific therapeutic area. We are seeing long-acting therapies, vaccines utilizing different platforms, and even with the mRNA technology, we are keeping an eye on it because there's work happening in the TB space for mRNA and the oncology space. So, there is quite a lot to focus on these therapeutic areas and prioritize our resources to support them. The last thing is to improve our review timeframes, which remains a challenge. We have made improvements in the right direction, but it is still a challenge for us.

EF: How is SAHPRA innovating on guidelines and policies, or implementing new policies, to enable the inclusion of new innovations in South Africa?

BS: Sure, one of the things we do is consult extensively with our industry, and we have structured and transparent platforms through which we engage with them. This helps us understand what they are working on and allows them to provide feedback on the guidelines we issue. We aim to ensure that our guidelines are relevant to their context, and while we may agree on some things, there are other things we may not agree on. We have this platform to engage with them. Additionally, we have adopted a principle of relying on EMA guidelines, especially for multinationals. If a company has gone through an EMA process, it should not be too complex for them to align with SAHPRA's requirements. While there may be nuances here and there, generally, if you submit to EMA, you should be able to submit to SAHPRA as well.

EF: Could you elaborate on your digital agenda and explain how it is improving your role in ensuring access to quality and safe products?

BS: Digitization is certainly cored to driving efficiency. There are areas that have already been digitized. We have the Med Safety app for reporting adverse events following immunization. We also had to pivot at the beginning of Covid because we were working remotely, and we had to receive dossiers through a digital platform. Our evaluators were working remotely and had to review the dossiers on this digital platform. Digitization is helpful for reporting and monitoring perspectives. It allows us to see our review timeframes, assess our efficiency, identify rate-limiting steps, and evaluate our capacity. When we are digital, we can easily obtain this data. Hence, it is a significant project, and we are getting a regulatory information management system in the next few weeks, which will be end-to-end and enable applicants to submit online. They can track where their dossiers are, and we can issue queries and receive responses through that platform. We are hoping for a lot more efficiency.

EF: How is digitalization evolving in South Africa, and what is your perception on this?

BS: The Department of Health has been working on getting electronic patient records for quite some time now, as they are crucial for coordination, procurement, and patient management. We are seeing a lot of uptakes in the private sector, where patients can authorize the sharing of their records between clinicians. As a regulator, electronic patient records are important for us from a vigilance perspective. It allows us to link vigilance data with patient records.

EF: What is the role of SAHPRA and their perspective on encouraging more local capacity to make South Africa a hub for the region?

BS: It is a difficult situation because, as a regulator, we sometimes have to enforce regulations, while at other times we need to facilitate them. What we have found is that we need to have a team dedicated to supporting emerging entities because many of them are unfamiliar with the regulatory process. We also need a team to enforce regulations. Although we may not be able to split the roles this way, the important thing is that we can support these entities when necessary.

EF: I would like to ask, as someone who has been with SAHPRA for a long time and has made a significant impact, how would you like to be remembered?

BS:  Different stakeholders will remember me differently. The South African industry, for example, would hopefully remember me as a flexible and open-minded regulator who aimed to enable rather than restrict. As for my staff, I hope they will remember me as a leader who challenged them to think outside of the box and to find solutions to regulatory challenges within the bounds of proper governance. I always look for ways to work around obstacles. In terms of the global community, I hope they will remember my tenure at SAHPRA as one in which we worked hard to align with global best practices and establish ourselves as a regulator that others could rely on. Ultimately, my goal is to have contributed to SAHPRA's reputation as a globally renowned regulatory authority.

EF: What would be your final message?

BS: My final message would be about the patient, who is at the heart of everything we do in the sector. We must strive to ensure that the patient is the focus of every decision we make, whether it is about the NHI or regulatory decisions. Empathy is also crucial in this sector. Many of us work long hours and face challenging conditions, but we are driven by our passion and love for what we do. It is not just about making lots of money; it is about helping people and making a positive impact on their lives. So, let us all keep the patient at the forefront of our minds and continue to work with empathy, passion, and dedication.

April 2023
South Africa